Aetna Medicare Advantra Central Value (PPO), Aetna Medicare Advantra Credit Value (PPO),
Aetna Medicare Advantra Preferred Plan (PPO), Aetna Medicare Advantra Silver (PPO), Aetna
Medicare Advantra Value (PPO), Aetna Medicare Choice II Plan (PPO), Aetna Medicare Choice
Plan (PPO), Aetna Medicare Credit Plan (PPO), Aetna Medicare Discover Value Plan (PPO),
Aetna Medicare DMG Prime (PPO), Aetna Medicare Elite (PPO), Aetna Medicare Elite Plan
(PPO), Aetna Medicare Elite Plan 2 (PPO), Aetna Medicare Elite Plan 3 (PPO), Aetna Medicare
Essential Elite Plan (PPO), Aetna Medicare Essential Plan (PPO), Aetna Medicare Explorer Elite
(PPO), Aetna Medicare Explorer Plan (PPO), Aetna Medicare Explorer Premier (PPO), Aetna
Medicare Explorer Premier 2 (PPO), Aetna Medicare Explorer Premier Plan (PPO), Aetna
Medicare Explorer Premier Plus (PPO), Aetna Medicare Explorer Value (PPO), Aetna Medicare
Freedom Core Plan (PPO), Aetna Medicare Freedom Plan (PPO), Aetna Medicare Freedom
Preferred Plan (PPO), Aetna Medicare Gold Plan (PPO), Aetna Medicare Platinum Plan (PPO),
Aetna Medicare Plus Plan (PPO), Aetna Medicare Preferred Premium Plan (PPO), Aetna
Medicare Premier (PPO), Aetna Medicare Premier (Regional PPO), Aetna Medicare Premier 1
(PPO), Aetna Medicare Premier 2 (PPO), Aetna Medicare Premier Plan (PPO), Aetna Medicare
Premier Plus (PPO), Aetna Medicare Premier Plus 2 (PPO), Aetna Medicare Premier Plus 2
(Regional PPO), Aetna Medicare Premier Plus Plan (PPO), Aetna Medicare Prime (PPO), Aetna
Medicare Prime 1 (PPO), Aetna Medicare Prime Credit (PPO), Aetna Medicare Prime Premier
(PPO), Aetna Medicare Select Plan (PPO), Aetna Medicare SNJ Prime Elite (PPO), Aetna
Medicare The Valley Plan (PPO), Aetna Medicare Value (PPO), Aetna Medicare Value Plan
(PPO), Aetna Medicare Value Plus Plan (PPO)
Last Updated: 04/01/2022
ABIRATERONE
Products Affected
Abiraterone Acetate
Zytiga TABS 500MG
NR_0009_3741 09/2014
Formulary ID: 22007: version 12 1
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Node-positive (N1), non-metastatic (M0) prostate cancer
Exclusion
Criteria
N/A
Required
Medical
Information
The requested drug will be used in combination with a gonadotropin-
releasing hormone (GnRH) analog or after bilateral orchiectomy.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
2
ACITRETIN
Products Affected
Acitretin
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Prevention of non-melanoma skin cancers in high risk individuals, Lichen
planus, Keratosis follicularis (Darier Disease)
Exclusion
Criteria
N/A
Required
Medical
Information
Psoriasis: The patient has experienced an inadequate treatment response,
intolerance, or the patient has a contraindication to methotrexate or
cyclosporine.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
3
ACTIMMUNE
Products Affected
Actimmune
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Mycosis fungoides, Sezary syndrome.
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
4
ADEMPAS
Products Affected
Adempas
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For pulmonary arterial hypertension (PAH) (World Health Organization
[WHO] Group 1): PAH was confirmed by right heart catheterization. For
PAH new starts only: 1) pretreatment mean pulmonary arterial pressure is
greater than 20 mmHg, AND 2) pretreatment pulmonary capillary wedge
pressure is less than or equal to 15 mmHg, AND 3) pretreatment
pulmonary vascular resistance is greater than or equal to 3 Wood units.
For chronic thromboembolic pulmonary hypertension (CTEPH) (WHO
Group 4): 1) Patient has persistent or recurrent CTEPH after pulmonary
endarterectomy (PEA), OR 2) Patient has inoperable CTEPH with the
diagnosis confirmed by right heart catheterization AND by computed
tomography (CT), magnetic resonance imaging (MRI), or pulmonary
angiography.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
5
AIMOVIG
Products Affected
Aimovig
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
1) The patient received at least 3 months of treatment with the requested
drug, and the patient had a reduction in migraine days per month from
baseline, OR 2) The patient experienced an inadequate treatment response
with a 4-week trial of any of the following: Antiepileptic drugs (AEDs),
Beta-adrenergic blocking agents, Antidepressants, OR 3) The patient
experienced an intolerance or has a contraindication that would prohibit a
4-week trial of any of the following: Antiepileptic drugs (AEDs), Beta-
adrenergic blocking agents, Antidepressants.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Initial 3 months, Reauthorization Plan Year
Other Criteria
N/A
6
ALECENSA
Products Affected
Alecensa
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Recurrent ALK-positive non-small cell lung cancer (NSCLC), brain
metastases from ALK-positive NSCLC.
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
7
ALOSETRON
Products Affected
Alosetron Hydrochloride
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
1) The requested drug is being prescribed for a biological female or a
person that self-identifies as a female with a diagnosis of severe diarrhea-
predominant irritable bowel syndrome (IBS) AND 2) Chronic IBS
symptoms lasting at least 6 months AND 3) Gastrointestinal tract
abnormalities have been ruled out AND 4) Inadequate response to one
conventional therapy (e.g., antispasmodics, antidepressants,
antidiarrheals).
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
8
ALPHA1-PROTEINASE INHIBITOR
Products Affected
Prolastin-c
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For alpha1-proteinase inhibitor deficiency: Patient must have 1) clinically
evident emphysema and 2) pretreatment serum alpha1-proteinase inhibitor
level less than 11 micromol/L (80 mg/dL by radial immunodiffusion or 50
mg/dL by nephelometry).
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
9
ALUNBRIG
Products Affected
Alunbrig
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Recurrent ALK-positive non-small cell lung cancer (NSCLC), brain
metastases from ALK-positive NSCLC.
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
10
AMBRISENTAN
Products Affected
Ambrisentan
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
Pulmonary arterial hypertension (PAH) (World Health Organization
[WHO] Group 1): Diagnosis was confirmed by right heart catheterization.
For PAH new starts only: 1) Pretreatment mean pulmonary arterial
pressure is greater than 20 mmHg, 2) Pretreatment pulmonary capillary
wedge pressure is less than or equal to 15 mmHg, and 3) Pretreatment
pulmonary vascular resistance is greater than or equal to 3 Wood units.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
11
ARCALYST
Products Affected
Arcalyst
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Prevention of gout flares in patients initiating or continuing urate-
lowering therapy.
Exclusion
Criteria
N/A
Required
Medical
Information
For prevention of gout flares in patients initiating or continuing urate-
lowering therapy (e.g., allopurinol) (new starts): 1) two or more gout
flares within the previous 12 months, AND 2) inadequate response,
intolerance or contraindication to maximum tolerated doses of a non-
steroidal anti-inflammatory drug (NSAID) and colchicine, AND 3)
concurrent use with urate-lowering therapy. For prevention of gout flares
in patients initiating or continuing urate-lowering therapy (e.g.,
allopurinol) (continuation): 1) patient must have achieved or maintained a
clinical benefit (i.e., a fewer number of gout attacks or fewer flare days)
compared to baseline, AND 2) continued use of urate-lowering therapy
concurrently with the requested drug.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
For prevention of gout flares: 4 months. Other: Plan Year
Other Criteria
N/A
12
ARMODAFINIL
Products Affected
Armodafinil
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
1) The patient has a diagnosis of narcolepsy and the diagnosis is
confirmed by sleep lab evaluation OR 2) The patient has a diagnosis of
Shift Work Disorder (SWD) OR 3) The patient has a diagnosis of
obstructive sleep apnea (OSA) and the diagnosis is confirmed by
polysomnography.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
13
ASPARLAS
Products Affected
Asparlas
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
Patient age 21 years or less
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
14
AUSTEDO
Products Affected
Austedo
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Tourette's syndrome
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
15
AVONEX
Products Affected
Avonex INJ 30MCG/0.5ML
Avonex Pen
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
16
AYVAKIT
Products Affected
Ayvakit
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Myeloid and lymphoid neoplasms with eosinophilia, gastrointestinal
stromal tumor (GIST) for unresectable, recurrent, or metastatic disease
without platelet-derived growth factor receptor alpha (PDGFRA) exon 18
mutation
Exclusion
Criteria
N/A
Required
Medical
Information
For myeloid and lymphoid neoplasms with eosinophilia, the patient meets
all of the following criteria: 1) the disease is FIP1L1- PDGFRA
rearrangement-positive, AND 2) The disease harbors a PDGFRA D842A
mutation, AND 3) The disease is resistant to imatinib. For GIST, the
patient meets either of the following criteria: 1) The disease harbors
PDGFRA exon 18 mutation, including PDGFRA D842V mutations, OR
2) The requested drug will be used after failure on at least two Food and
Drug Administration (FDA)-approved therapies in unresectable,
recurrent, or metastatic disease without PDGFRA exon 18 mutation. For
advanced systemic mastocytosis (AdvSM): 1) the patient has a diagnosis
of advanced systemic mastocytosis including aggressive systemic
mastocytosis (ASM), systemic mastocytosis with associated
hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) AND
2) the patient has a platelet count of greater than or equal to 50,000/mcL.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
17
BALVERSA
Products Affected
Balversa
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
18
BANZEL
Products Affected
Banzel TABS
Rufinamide
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
1 year of age or older
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
19
BELEODAQ
Products Affected
Beleodaq
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Adult T-cell leukemia/lymphoma, mycosis fungoides/Sezary syndrome,
extranodal NK/T-cell lymphoma (nasal type), hepatosplenic gamma-delta
T-cell lymphoma, and primary cutaneous anaplastic large cell lymphoma
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
20
BENLYSTA
Products Affected
Benlysta
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
For patients new to therapy: severe active central nervous system lupus.
Required
Medical
Information
For systemic lupus erythematosus (SLE): 1) Patient is currently receiving
a stable standard therapy regimen (e.g., corticosteroid or antimalarial) for
SLE OR 2) patient is not currently receiving stable standard therapy
regimen for SLE because patient tried and had an inadequate response or
intolerance to stable standard therapy regimen. For lupus nephritis: 1)
Patient is currently receiving a stable standard therapy regimen (e.g.,
corticosteroid) for lupus nephritis OR 2) patient is not currently receiving
a stable standard therapy regimen for lupus nephritis because patient tried
and had an inadequate response or intolerance to a stable standard therapy
regimen.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
21
BESREMI
Products Affected
Besremi
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
22
BETASERON
Products Affected
Betaseron
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
23
BEVACIZUMAB
Products Affected
Zirabev
24
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Breast cancer, central nervous system (CNS) tumor types: adult low-grade
(WHO Grade II) infiltrative supratentorial
astrocytoma/oligodendroglioma, adult intracranial and spinal
ependymoma, anaplastic gliomas, adult medulloblastoma, primary central
nervous system lymphoma, meningiomas, limited and extensive brain
metastases, and metastatic spine tumors, malignant pleural mesothelioma,
ovarian cancer/fallopian tube cancer/primary peritoneal cancer types:
carcinosarcoma (malignant mixed Mullerian tumors), clear cell
carcinoma, mucinous carcinoma, grade 1 endometrioid carcinoma, low-
grade serous carcinoma, ovarian borderline epithelial tumors (low
malignant potential) with invasive implants, and malignant sex cord-
stromal tumors, soft tissue sarcoma types: angiosarcoma and solitary
fibrous tumor/hemangiopericytoma, uterine neoplasms, endometrial
cancer, vulvar squamous cell carcinoma, and ophthalmic-related
disorders: diabetic macular edema, neovascular (wet) age-related macular
degeneration including polypoidal choroidopathy and retinal angiomatous
proliferation subtypes, macular edema following retinal vein occlusion,
proliferative diabetic retinopathy, choroidal neovascularization,
neovascular glaucoma and retinopathy of prematurity, small bowel
adenocarcinoma.
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
Coverage under Part D will be denied if coverage is available under Part
A or Part B as the medication is prescribed and dispensed or administered
for the individual.
25
BEXAROTENE
Products Affected
Bexarotene
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Mycosis fungoides, Sezary syndrome, CD30-positive primary cutaneous
anaplastic large cell lymphoma, CD30-positive lymphomatoid papulosis.
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
26
BLENREP
Products Affected
Blenrep
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
27
BOSENTAN
Products Affected
Bosentan
Tracleer TBSO
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For pulmonary arterial hypertension (PAH) (World Health Organization
[WHO] Group 1): Diagnosis was confirmed by right heart catheterization.
For PAH new starts only: 1) Pretreatment mean pulmonary arterial
pressure is greater than 20 mmHg, 2) Pretreatment pulmonary capillary
wedge pressure is less than or equal to 15 mmHg, and 3) Pretreatment
pulmonary vascular resistance is greater than or equal to 3 Wood units.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
28
BOSULIF
Products Affected
Bosulif
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+
ALL)
Exclusion
Criteria
N/A
Required
Medical
Information
For chronic myeloid leukemia (CML) or acute lymphoblastic leukemia
(ALL): Diagnosis was confirmed by detection of the Philadelphia
chromosome or BCR-ABL gene. For CML, including patients newly
diagnosed with CML and patients who have received a hematopoietic
stem cell transplant: patient has experienced resistance or intolerance to
imatinib or dasatinib. If patient experienced resistance to an alternative
tyrosine kinase inhibitor for CML, patient is negative for all of the
following mutations: T315I, G250E, V299L, and F317L.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
29
BRAFTOVI
Products Affected
Braftovi CAPS 75MG
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Adjuvant systemic therapy for cutaneous melanoma
Exclusion
Criteria
N/A
Required
Medical
Information
For colorectal cancer: The patient must meet both of the following
criteria: 1) Tumor is positive for BRAF V600E mutation, 2) The
requested drug will be used for either of the following: a) as subsequent
therapy for advanced or metastatic disease, or b) as primary treatment for
unresectable metachronous metastases. For cutaneous melanoma: The
patient must meet all of the following criteria: 1) Tumor is positive for
BRAF V600 activating mutation (e.g., V600E or V600K), 2) The
requested drug will be used in combination with binimetinib, and 3) The
requested drug will be used for either of the following: a) unresectable or
metastatic disease, or b) adjuvant systemic therapy.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
30
BRIVIACT
Products Affected
Briviact ORAL SOLN
Briviact TABS
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
1) The patient has experienced an inadequate treatment response,
intolerance, or contraindication to a generic anticonvulsant AND 2) If the
patient is 4 years of age or older, the patient has experienced an
inadequate treatment response, intolerance, or contraindication to any of
the following: Aptiom, Vimpat, Xcopri, Spritam.
Age Restrictions
1 month of age or older
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
31
BRIVIACT INJ
Products Affected
Briviact INJ
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
1) The patient has experienced an inadequate treatment response,
intolerance, or contraindication to a generic anticonvulsant AND 2) If the
patient is 4 years of age or older, the patient has experienced an
inadequate treatment response, intolerance, or contraindication to any of
the following: Aptiom, Vimpat, Xcopri, Spritam.
Age Restrictions
1 month of age or older
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
32
BRUKINSA
Products Affected
Brukinsa
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
33
BUPRENORPHINE
Products Affected
Buprenorphine Hcl SUBL
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
The requested drug is being prescribed for the treatment of opioid use
disorder AND patient meets one of the following: 1) The patient is
pregnant or breastfeeding, and the requested drug is being prescribed for
induction therapy and/or subsequent maintenance therapy for treatment of
opioid use disorder OR 2) The requested drug is being prescribed for
induction therapy for transition from opioid use to treatment of opioid use
disorder OR 3) The requested drug is being prescribed for maintenance
therapy for treatment of opioid use disorder in a patient who is intolerant
to naloxone.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
12 months
Other Criteria
N/A
34
BUPRENORPHINE PATCH
Products Affected
Buprenorphine PTWK
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
1) The requested drug is being prescribed for pain associated with cancer,
sickle cell disease, a terminal condition, or pain being managed through
palliative care OR 2) The requested drug is being prescribed for pain
severe enough to require daily, around-the-clock, long-term treatment in a
patient who has been taking an opioid AND 3) The patient can safely take
the requested dose based on their history of opioid use [Note: This drug
should be prescribed only by healthcare professionals who are
knowledgeable in the use of potent opioids for the management of chronic
pain.] AND 4) The patient has been evaluated and the patient will be
monitored for the development of opioid use disorder AND 5) This
request is for continuation of therapy for a patient who has been receiving
an extended-release opioid agent for at least 30 days OR the patient has
taken an immediate-release opioid for at least one week.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
35
CABOMETYX
Products Affected
Cabometyx
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Non-small cell lung cancer
Exclusion
Criteria
N/A
Required
Medical
Information
For renal cell carcinoma: The disease is advanced, relapsed, or stage IV.
For non-small cell lung cancer: 1) The disease is rearranged during
transfection (RET) positive AND 2) the disease is recurrent, advanced, or
metastatic. For hepatocellular carcinoma: the requested drug will be used
as subsequent treatment.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
36
CALCIPOTRIENE
Products Affected
Calcipotriene CREA
Calcipotriene OINT
Calcipotriene SOLN
Calcipotriene/betamethasone
Dipropionate OINT
Calcitriol OINT
Enstilar
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
1) The requested drug is being prescribed for the treatment of psoriasis
AND 2) The patient experienced an inadequate treatment response,
intolerance, or the patient has a contraindication to a topical steroid.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
37
CALQUENCE
Products Affected
Calquence
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Waldenstrom macroglobulinemia/lymphoplasmacytic lymphoma
Exclusion
Criteria
N/A
Required
Medical
Information
For chronic lymphocytic leukemia or small lymphocytic lymphoma: the
patient has experienced an intolerable adverse event with ibrutinib.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
38
CAPLYTA
Products Affected
Caplyta
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
The patient experienced an inadequate treatment response, intolerance, or
contraindication to one of the following generic products: A) aripiprazole,
B) asenapine, C) olanzapine, D) quetiapine, E) risperidone, F) ziprasidone
AND the patient experienced an inadequate treatment response,
intolerance, or contraindication to one of the following brand products: A)
Latuda, B) Rexulti, C) Secuado.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
39
CAPRELSA
Products Affected
Caprelsa
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Differentiated thyroid carcinoma: papillary, follicular, and Hurthle cell.
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
40
CARAC
Products Affected
Fluorouracil CREA 0.5%
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
Patients who are pregnant or may become pregnant. Patients with
dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
Required
Medical
Information
If being used as part of a compounded product, all active ingredients in
the compounded product are FDA approved for topical use.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
3 months
Other Criteria
N/A
41
CARBAGLU
Products Affected
Carbaglu
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For N-acetylglutamate synthase (NAGS) deficiency: Diagnosis of NAGS
deficiency was confirmed by enzymatic or genetic testing.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
42
CAYSTON
Products Affected
Cayston
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For treatment of respiratory symptoms in cystic fibrosis patients: 1)
Pseudomonas aeruginosa is present in the patient's airway cultures OR 2)
The patient has a history of pseudomonas aeruginosa infection or
colonization in the airways.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
43
CERDELGA
Products Affected
Cerdelga
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For Gaucher disease, the diagnosis was confirmed by an enzyme assay
demonstrating a deficiency of beta-glucocerebrosidase enzyme activity or
by genetic testing. The patient's CYP2D6 metabolizer status has been
established using an FDA-cleared test. The patient is a CYP2D6 extensive
metabolizer, an intermediate metabolizer, or a poor metabolizer.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
44
CHANTIX
Products Affected
Apo-varenicline
Chantix TABS 0.5MG, 1MG
Chantix Continuing Month Pak
Chantix Starting Month Pak
Varenicline Tartrate
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
6 months
Other Criteria
This Prior Authorization requirement applies after the member has
received a cumulative 24 weeks of therapy in a Plan Year.
45
CHLORDIAZEPOXIDE - 65
Products Affected
Chlordiazepoxide Hcl CAPS 10MG,
5MG
Chlordiazepoxide Hydrochloride
CAPS 25MG
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For all indications: the prescriber must acknowledge the benefit of
therapy with the prescribed medication outweighs the potential risks for
the patient. (Note: The American Geriatrics Society identifies the use of
this medication as potentially inappropriate in older adults, meaning it is
best avoided, prescribed at reduced dosage, or used with caution or
carefully monitored.) For the management of anxiety disorders: 1) the
requested drug is being used concurrently with a selective serotonin
reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor
(SNRI) until SSRI/SNRI is effective for the symptoms of anxiety, OR 2)
the patient has experienced an inadequate treatment response, intolerance,
or has a contraindication to AT LEAST TWO agents from the following
classes: a) selective serotonin reuptake inhibitors (SSRIs), OR b)
serotonin-norepinephrine reuptake inhibitors (SNRIs).
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Short-term relief anxiety-preop apprehens and anx-1 mo, Anxiety
Disorder-4 mo, Alc Withdrawal-PlanYR
Other Criteria
This Prior Authorization requirement only applies to patients 65 years of
age or older.
46
CLOBAZAM
Products Affected
Clobazam
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
2 years of age or older
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
47
CLOMIPRAMINE
Products Affected
Clomipramine Hcl CAPS
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Depression, Panic Disorder
Exclusion
Criteria
N/A
Required
Medical
Information
1) The requested drug is being prescribed for one of the following:
Obsessive-Compulsive Disorder (OCD) or Panic Disorder AND 2) The
patient has experienced an inadequate treatment response, intolerance, or
the patient has a contraindication to any of the following: a serotonin and
norepinephrine reuptake inhibitor (SNRI) or a selective serotonin
reuptake inhibitor (SSRI) OR 3) The requested drug is being prescribed
for Depression AND 4) The patient has experienced an inadequate
treatment response, intolerance, or the patient has a contraindication to
two of the following: serotonin and norepinephrine reuptake inhibitors
(SNRIs), selective serotonin reuptake inhibitors (SSRIs), mirtazapine,
bupropion.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
48
CLORAZEPATE
Products Affected
Clorazepate Dipotassium TABS
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For all indications: the prescriber must acknowledge the benefit of
therapy with the requested drug outweighs the potential risks for the
patient. (Note: The American Geriatrics Society identifies the use of this
medication as potentially inappropriate in older adults, meaning it is best
avoided, prescribed at reduced dosage, or used with caution or carefully
monitored.) For the management of anxiety disorders: 1) the requested
drug is being used concurrently with a selective serotonin reuptake
inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
until the SSRI/SNRI becomes effective for the symptoms of anxiety OR
2) the patient has experienced an inadequate treatment response,
intolerance, or has a contraindication to AT LEAST TWO agents from the
following classes: a) selective serotonin reuptake inhibitors (SSRIs) OR
b) serotonin-norepinephrine reuptake inhibitors (SNRIs).
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Short-term relief anxiety-1 month, Anxiety Disorders-4 months, All other
Diagnoses-Plan Year
Other Criteria
This Prior Authorization requirement only applies to patients 65 years of
age or older.
49
CLOZAPINE ODT
Products Affected
Clozapine Odt
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
50
COLY-MYCIN
Products Affected
Colistimethate Sodium INJ
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
Intravenous (IV) or intramuscular (IM) use only. Administration will not
be via nebulizer. (Note: CMS endorsed compendia do not support
inhalation/nebulization of colistimethate.). The infection is proven or
strongly suspected to be caused by susceptible bacteria based on: 1)
culture and susceptibility information OR 2) local epidemiology and
susceptibility patterns.
Age Restrictions
N/A
Prescriber
Restrictions
Prescribed by or in consultation with an infectious disease specialist
Coverage
Duration
Initial approval: 3 months, Renewal: Plan Year
Other Criteria
N/A
51
COMETRIQ
Products Affected
Cometriq
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Non-small cell lung cancer (NSCLC), differentiated thyroid carcinoma:
papillary, follicular, and Hurthle cell.
Exclusion
Criteria
N/A
Required
Medical
Information
For NSCLC: The requested medication is used for NSCLC when the
patient's disease expresses rearranged during transfection (RET) gene
rearrangements.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
52
COPIKTRA
Products Affected
Copiktra
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Gastric MALT lymphoma, non-gastric MALT lymphoma, nodal marginal
zone lymphoma, splenic marginal zone lymphoma
Exclusion
Criteria
N/A
Required
Medical
Information
For follicular lymphoma, gastric MALT lymphoma, non-gastric MALT
lymphoma, nodal marginal zone lymphoma, and splenic marginal zone
lymphoma: the requested drug will be used as subsequent therapy after at
least 2 prior therapies.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
53
COTELLIC
Products Affected
Cotellic
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Central nervous system (CNS) cancer (i.e., glioma, meningioma,
astrocytoma)
Exclusion
Criteria
N/A
Required
Medical
Information
For adjuvant treatment of melanoma, and central nervous system (CNS)
cancer (i.e., glioma, meningioma, astrocytoma): The patient must meet
both of the following criteria: 1) The tumor is positive for BRAF V600
activating mutation (e.g., V600E or V600K), and 2) The requested drug
will be used in combination with vemurafenib. For unresectable or
metastatic melanoma: The patient must meet both of the following
criteria: 1) The tumor is positive for BRAF V600 activating mutation
(e.g., V600E or V600K), and 2) The requested drug will be used in
combination with vemurafenib (with or without atezolizumab).
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
54
CYSTAGON
Products Affected
Cystagon
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For nephropathic cystinosis: Diagnosis of nephropathic cystinosis was
confirmed by the presence of increased cystine concentration in
leukocytes or by genetic testing.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
55
CYSTARAN
Products Affected
Cystaran
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For cystinosis: 1) Diagnosis of cystinosis was confirmed by the presence
of increased cystine concentration in leukocytes or by genetic testing, and
2) Patient has corneal cystine crystal accumulation.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
56
DALFAMPRIDINE
Products Affected
Dalfampridine Er
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For multiple sclerosis, patient must meet the following: For new starts,
prior to initiating therapy, patient meets the following: patient
demonstrates sustained walking impairment. For continuation of therapy,
patient meets the following: patient must have experienced an
improvement in walking speed OR other objective measure of walking
ability since starting the requested drug.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
57
DAURISMO
Products Affected
Daurismo
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Post induction therapy following response to previous therapy with the
same regimen for acute myeloid leukemia (AML). Relapsed/refractory
AML as a component of repeating the initial successful induction
regimen.
Exclusion
Criteria
N/A
Required
Medical
Information
For acute myeloid leukemia: 1) the requested medication must be used in
combination with cytarabine, 2) the patient is 75 years of age or older OR
has comorbidities that preclude intensive chemotherapy, and 3) the
requested medication will be used as treatment for induction therapy,
post-induction therapy, or relapsed or refractory disease.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
58
DEFERASIROX
Products Affected
Deferasirox
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For chronic iron overload due to blood transfusions: pretreatment serum
ferritin level is greater than 1000 mcg/L.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
59
DEMSER
Products Affected
Metyrosine
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
60
DESVENLAFAXINE
Products Affected
Desvenlafaxine Er
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
Patient has experienced an inadequate treatment response, intolerance, or
the patient has a contraindication to TWO of the following: serotonin and
norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake
inhibitors (SSRIs), mirtazapine, bupropion.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
61
DHE NASAL
Products Affected
Dihydroergotamine Mesylate
NASAL SOLN
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
1) The patient has experienced an inadequate treatment response to one
triptan 5-HT1 receptor agonist OR 2) The patient has experienced an
intolerance to one triptan 5-HT1 receptor agonist OR 3) The patient has a
contraindication that would prohibit a trial of triptan 5-HT1 receptor
agonists.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
62
DIACOMIT
Products Affected
Diacomit
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
63
DIAZEPAM
Products Affected
Diazepam CONC
Diazepam INJ 5MG/ML
Diazepam ORAL SOLN 5MG/5ML
Diazepam TABS
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For all indications: the prescriber must acknowledge the benefit of
therapy with the requested drug outweighs the potential risks for the
patient. (Note: The American Geriatrics Society identifies the use of this
medication as potentially inappropriate in older adults, meaning it is best
avoided, prescribed at reduced dosage, or used with caution or carefully
monitored.) For the management of anxiety disorders: 1) the requested
drug is being used concurrently with a selective serotonin reuptake
inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
until the SSRI/SNRI becomes effective for the symptoms of anxiety, OR
2) The patient has experienced an inadequate treatment response,
intolerance, or has a contraindication to AT LEAST TWO agents from the
following classes: a) selective serotonin reuptake inhibitors (SSRIs), b)
serotonin-norepinephrine reuptake inhibitors (SNRIs).
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Short-term relief anx-1 mo, skeletal muscle spasm-3 mo, Anx Disorders-4
mo, Other Diagnoses-PlanYR
Other Criteria
This Prior Authorization requirement only applies to patients 65 years of
age or older.
64
DICLOFENAC GEL 1%
Products Affected
Diclofenac Sodium GEL 1%
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
The patient has osteoarthritis pain in joints susceptible to topical treatment
such as feet, ankles, knees, hands, wrists, or elbows.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
65
DICLOFENAC SOLN
Products Affected
Pennsaid SOLN 2%
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
66
DOPTELET
Products Affected
Doptelet
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For thrombocytopenia associated with chronic liver disease: Baseline
platelet count prior to a scheduled procedure is less than 50,000/mcL. For
chronic immune thrombocytopenia (ITP): 1) For new starts: a) Patient has
had an inadequate response or is intolerant to a prior therapy such as
corticosteroids or immunoglobulins, AND b) Untransfused platelet count
at any point prior to the initiation of the requested medication is less than
30,000/mcL OR 30,000 to 50,000/mcL with symptomatic bleeding or risk
factor(s) for bleeding (e.g., undergoing a medical or dental procedure
where blood loss is anticipated, comorbidities such as peptic ulcer disease
and hypertension, anticoagulation therapy, profession or lifestyle that
predisposes patient to trauma). 2) For continuation of therapy, platelet
count response to the requested drug: a) Current platelet count is less than
or equal to 200,000/mcL OR b) Current platelet count is greater than
200,000/mcL and less than or equal to 400,000/mcL and dosing will be
adjusted to a platelet count sufficient to avoid clinically important
bleeding.
Age Restrictions
18 years of age or older
Prescriber
Restrictions
N/A
Coverage
Duration
Chronic liver disease: 1 month, ITP initial: 6 months, ITP reauthorization:
Plan Year
Other Criteria
N/A
67
DRIZALMA
Products Affected
Drizalma Sprinkle
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Cancer pain, chemotherapy-induced neuropathic pain
Exclusion
Criteria
N/A
Required
Medical
Information
1) The patient has tried duloxetine capsules OR 2) The patient is unable to
take duloxetine capsules for any reason (e.g., difficulty swallowing
capsules, requires nasogastric administration).
Age Restrictions
Generalized Anxiety Disorder - 7 years of age or older
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
68
DRONABINOL
Products Affected
Dronabinol
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For chemotherapy-induced nausea and vomiting (CINV): The patient is
receiving cancer chemotherapy AND has experienced an inadequate
treatment response, intolerance, or contraindication to one oral 5-HT3
receptor antagonist.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
6 months
Other Criteria
Coverage under Part D will be denied if coverage is available under Part
A or Part B as the medication is prescribed and dispensed or administered
for the individual.
69
DUEXIS
Products Affected
Ibuprofen/famotidine
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
The patient has tried two different regimens containing any combination
of a nonsteroidal anti-inflammatory drug (NSAID) and an acid blocker
from any of the following drug classes: H2-receptor antagonist (H2RA),
proton pump inhibitor (PPI).
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
70
EMSAM
Products Affected
Emsam
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
1) Patient has experienced an inadequate treatment response, intolerance,
or the patient has a contraindication to TWO of the following: serotonin
and norepinephrine reuptake inhibitors (SNRIs), selective serotonin
reuptake inhibitors (SSRIs), mirtazapine, bupropion OR 2) Patient is
unable to swallow oral formulations.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
71
ENBREL
Products Affected
Enbrel
Enbrel Mini
Enbrel Sureclick
72
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Hidradenitis suppurativa
Exclusion
Criteria
N/A
Required
Medical
Information
For moderately to severely active rheumatoid arthritis (new starts only):
1) Inadequate response, intolerance or contraindication to methotrexate
(MTX) OR 2) Inadequate response or intolerance to a prior biologic
disease-modifying antirheumatic drug (DMARD) or a targeted synthetic
DMARD. For active ankylosing spondylitis (new starts only): 1)
Inadequate response to a non-steroidal anti-inflammatory drug (NSAID)
trial, OR 2) Intolerance or contraindication to NSAIDs. For moderate to
severe plaque psoriasis (new starts only): 1) At least 3% of body surface
area (BSA) is affected OR crucial body areas (e.g., feet, hands, face, neck,
groin, intertriginous areas) are affected at the time of diagnosis, AND 2)
Patient meets any of the following: a) Patient has experienced an
inadequate response or intolerance to either phototherapy (e.g., UVB,
PUVA) or pharmacologic treatment with methotrexate, cyclosporine, or
acitretin, OR b) Pharmacologic treatment with methotrexate,
cyclosporine, or acitretin is contraindicated, OR c) Patient has severe
psoriasis that warrants a biologic DMARD as first-line therapy (i.e. at
least 10% of the BSA or crucial body areas (e.g., hands, feet, face, neck,
scalp, genitals/groin, intertriginous areas) are affected). For hidradenitis
suppurativa (new starts only): patient has severe, refractory disease.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
73
ENHERTU
Products Affected
Enhertu
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Non-small cell lung cancer with human epidermal growth factor receptor
2 (HER2) mutations, HER2-amplified and RAS and BRAF wild-type
colorectal cancer.
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
Coverage under Part D will be denied if coverage is available under Part
A or Part B as the medication is prescribed and dispensed or administered
for the individual.
74
EPCLUSA
Products Affected
Epclusa
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For hepatitis C virus (HCV): Infection confirmed by presence of HCV
RNA in the serum prior to starting treatment. Planned treatment regimen,
genotype, prior treatment history, presence or absence of cirrhosis
(compensated or decompensated [Child Turcotte Pugh class B or C]),
presence or absence of human immunodeficiency virus (HIV) coinfection,
presence or absence of resistance-associated substitutions where
applicable, liver and kidney transplantation status if applicable. Coverage
conditions and specific durations of approval will be based on current
AASLD treatment guidelines.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Criteria will be applied consistent with current AASLD-IDSA guidance.
Other Criteria
N/A
75
EPIDIOLEX
Products Affected
Epidiolex
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
76
EPO
Products Affected
Procrit
77
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Anemia due to myelodysplastic syndromes (MDS), anemia in congestive
heart failure (CHF), anemia in rheumatoid arthritis (RA), anemia due to
hepatitis C treatment (ribavirin in combination with either interferon alfa
or peginterferon alfa)
Exclusion
Criteria
Patients receiving chemotherapy with curative intent. Patients with
myeloid cancer.
Required
Medical
Information
Requirements regarding hemoglobin (Hgb) values exclude values due to a
recent transfusion. For initial approval: 1) for all uses except anemia due
to chemotherapy or myelodysplastic syndrome (MDS): patient has
adequate iron stores (defined as a transferrin saturation [TSAT] greater
than or equal to 20%) AND 2) for all uses except surgery: pretreatment
(no erythropoietin treatment in previous month) Hgb is less than 10 g/dL
(less than 9 g/dL for anemia in congestive heart failure), AND 3) for
MDS: pretreatment serum erythropoietin level is 500 international units/L
or less. For reauthorizations (patient received erythropoietin treatment in
previous month) in all uses except surgery: 1) patient has received at least
12 weeks of erythropoietin therapy, AND 2) patient responded to
erythropoietin therapy, AND 3) current Hgb is less than 12 g/dL, AND 4)
for all uses except anemia due to chemotherapy or MDS: patient has
adequate iron stores (defined as a TSAT greater than or equal to 20%).
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
16 weeks
Other Criteria
Coverage includes use in anemia in patients whose religious beliefs forbid
blood transfusions. Coverage under Part D will be denied if coverage is
available under Part A or Part B as the medication is prescribed and
dispensed or administered for the individual (e.g., used for treatment of
anemia for a patient with chronic renal failure who is undergoing dialysis,
or furnished from physician's supply incident to a physician service).
78
ERIVEDGE
Products Affected
Erivedge
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Adult medulloblastoma
Exclusion
Criteria
N/A
Required
Medical
Information
For adult medulloblastoma: patient has received chemotherapy previously
AND has tumor(s) with mutations in the sonic hedgehog pathway
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
79
ERLEADA
Products Affected
Erleada
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
The requested drug will be used in combination with a gonadotropin-
releasing hormone (GnRH) analog or after bilateral orchiectomy.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
80
ERLOTINIB
Products Affected
Erlotinib Hydrochloride
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Recurrent or advanced non-small cell lung cancer (NSCLC), recurrent
chordoma, relapsed or stage IV renal cell carcinoma (RCC), brain
metastases from NSCLC.
Exclusion
Criteria
N/A
Required
Medical
Information
For NSCLC (including brain metastases from NSCLC): 1) the disease is
recurrent, advanced, or metastatic and 2) the patient has sensitizing EGFR
mutation-positive disease. For pancreatic cancer: the disease is locally
advanced, unresectable, or metastatic.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
81
ESBRIET
Products Affected
Esbriet
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For idiopathic pulmonary fibrosis (Initial Review Only): 1) a high-
resolution computed tomography (HRCT) study of the chest or a lung
biopsy reveals the usual interstitial pneumonia (UIP) pattern, OR 2)
HRCT study of the chest reveals a result other than the UIP pattern (e.g.,
probable UIP, indeterminate for UIP) and the diagnosis is supported either
by a lung biopsy or by a multidisciplinary discussion between at least a
radiologist and pulmonologist who are experienced in idiopathic
pulmonary fibrosis if a lung biopsy has not been conducted.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
82
EVEROLIMUS
Products Affected
Afinitor TABS 10MG
Afinitor Disperz
Everolimus TABS 10MG, 2.5MG,
5MG, 7.5MG
Everolimus TBSO
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Classic Hodgkin lymphoma, thymomas and thymic carcinomas,
Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma, soft
tissue sarcoma (perivascular epithelioid cell tumors (PEComa) and
lymphangioleiomyomatosis subtypes), gastrointestinal stromal tumors,
neuroendocrine tumors of the thymus, thyroid carcinoma (papillary,
Hurthle cell, and follicular), endometrial carcinoma.
Exclusion
Criteria
N/A
Required
Medical
Information
For breast cancer: 1) The disease is recurrent or metastatic hormone
receptor (HR)-positive, human epidermal growth factor receptor 2
(HER2)-negative, AND 2) The requested medication is prescribed in
combination with exemestane, fulvestrant, or tamoxifen, AND 3) The
requested medication is used for subsequent treatment. For renal cell
carcinoma: The disease is relapsed, advanced, or stage IV. For
subependymal giant cell astrocytoma (SEGA): The requested drug is
given as adjuvant treatment.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
83
EXKIVITY
Products Affected
Exkivity
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
84
FANAPT
Products Affected
Fanapt
Fanapt Titration Pack
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
The patient experienced an inadequate treatment response, intolerance, or
contraindication to one of the following generic products: A) aripiprazole,
B) asenapine, C) olanzapine, D) quetiapine, E) risperidone, F) ziprasidone
AND the patient experienced an inadequate treatment response,
intolerance, or contraindication to one of the following brand products: A)
Latuda, B) Rexulti, C) Secuado.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
85
FARYDAK
Products Affected
Farydak
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
86
FASENRA
Products Affected
Fasenra
Fasenra Pen
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For severe asthma: For initial therapy: 1) Either a) Patient has baseline
blood eosinophil count of at least 150 cells per microliter OR b) Patient is
dependent on systemic corticosteroids, and 2) Patient has a history of
severe asthma despite current treatment with both of the following
medications at optimized doses: a) inhaled corticosteroid and b) additional
controller (long-acting beta2-agonist, leukotriene modifier, or sustained-
release theophylline). For continuation of therapy: Asthma control has
improved on treatment with the requested drug, as demonstrated by a
reduction in the frequency and/or severity of symptoms and exacerbations
or a reduction in the daily maintenance oral corticosteroid dose.
Age Restrictions
12 years of age or older
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
87
FENTANYL PATCH
Products Affected
Fentanyl PT72
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
1) The requested drug is being prescribed for pain associated with cancer,
sickle cell disease, a terminal condition, or pain being managed through
palliative care OR 2) The requested drug is being prescribed for pain
severe enough to require daily, around-the-clock, long-term treatment in a
patient who has been taking an opioid AND 3) The patient can safely take
the requested dose based on their history of opioid use [Note: This drug
should be prescribed only by healthcare professionals who are
knowledgeable in the use of potent opioids for the management of chronic
pain.] AND 4) The patient has been evaluated and the patient will be
monitored for the development of opioid use disorder AND 5) This
request is for continuation of therapy for a patient who has been receiving
an extended-release opioid agent for at least 30 days OR the patient has
taken an immediate-release opioid for at least one week.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
88
FETZIMA
Products Affected
Fetzima
Fetzima Titration Pack
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
The patient has experienced an inadequate treatment response,
intolerance, or the patient has a contraindication to TWO of the following:
serotonin and norepinephrine reuptake inhibitors (SNRIs), selective
serotonin reuptake inhibitors (SSRIs), mirtazapine, bupropion.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
89
FINTEPLA
Products Affected
Fintepla
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
90
FLUOROURACIL
Products Affected
Fluoroplex CREA
Fluorouracil CREA 5%
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
Patients who are pregnant or may become pregnant. Fluorouracil cream 5
percent only: Patients with dihydropyrimidine dehydrogenase (DPD)
enzyme deficiency.
Required
Medical
Information
Applies to new starts only. If being used as part of a compounded product,
all active ingredients in the compounded product are FDA approved for
topical use.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
3 months
Other Criteria
N/A
91
FORTAMET/GLUMETZA
Products Affected
Metformin Hydrochloride Er TB24
500MG
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
The patient has experienced an intolerance to generic Glucophage XR.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
92
FORTEO
Products Affected
Forteo INJ 620MCG/2.48ML
93
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For postmenopausal osteoporosis: patient has ONE of the following (1 or
2): 1) a history of fragility fracture, OR 2) A pre-treatment T-score of less
than or equal to -2.5 or pre-treatment T-score greater than -2.5 and less
than -1 with a high pre-treatment Fracture Risk Assessment Tool (FRAX)
fracture probability AND patient has ANY of the following: a) indicators
for higher fracture risk (e.g., advanced age, frailty, glucocorticoid therapy,
very low T-scores, or increased fall risk), OR b) patient has failed prior
treatment with or is intolerant to a previous injectable osteoporosis
therapy OR c) patient has had an oral bisphosphonate trial of at least 1-
year duration or there is a clinical reason to avoid treatment with an oral
bisphosphonate. For primary or hypogonadal osteoporosis in men: patient
has one of the following: 1) a history of osteoporotic vertebral or hip
fracture, OR 2) pre-treatment T-score of less than or equal to -2.5, OR 3)
pre-treatment T-score greater than -2.5 and less than -1 with a high pre-
treatment FRAX fracture probability. For glucocorticoid-induced
osteoporosis: Patient has had an oral bisphosphonate trial of at least 1-
year duration unless patient has a contraindication or intolerance to an
oral bisphosphonate, AND patient meets ANY of the following: 1) patient
has a history of fragility fracture, OR 2) a pre-treatment T-score of less
than or equal to -2.5, OR 3) pre-treatment T-score greater than -2.5 and
less than -1 with a high pre-treatment FRAX fracture probability.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
24 months total unless the patient remains at high risk for fracture and
benefit outweighs risk
Other Criteria
Patient has high FRAX fracture probability if the 10 year probability is
either greater than or equal to 20 percent for any major osteoporotic
fracture or greater than or equal to 3 percent for hip fracture. If
glucocorticoid treatment is greater than 7.5 mg (prednisone equivalent)
per day, the estimated risk score generated with FRAX should be
multiplied by 1.15 for major osteoporotic fracture and 1.2 for hip fracture.
94
FOTIVDA
Products Affected
Fotivda
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For advanced renal cell carcinoma: The following criteria must be met: 1)
The disease is relapsed or refractory, 2) The requested medication must be
used after at least two prior systemic therapies, and 3) The patient has
experienced disease progression or an intolerable adverse event with a
trial of cabozantinib.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
95
FYCOMPA
Products Affected
Fycompa
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For treatment of partial-onset seizures: 1) The patient experienced an
inadequate treatment response, intolerance, or contraindication to a
generic anticonvulsant AND 2) The patient has experienced an inadequate
treatment response, intolerance, or contraindication to any of the
following: Aptiom, Vimpat, Xcopri, Spritam. For adjunctive treatment of
primary generalized tonic-clonic seizures: 1) The patient experienced an
inadequate treatment response, intolerance, or contraindication to a
generic anticonvulsant AND 2) The patient experienced an inadequate
treatment response, intolerance, or contraindication to one of the
following: Vimpat, Spritam.
Age Restrictions
Partial-onset seizures: 4 years of age or older. Primary generalized tonic-
clonic seizures: 12 years of age or older
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
96
GATTEX
Products Affected
Gattex
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For short bowel syndrome (SBS) initial therapy: Adult patients were
dependent on parenteral support for at least 12 months. For SBS
continuation: Requirement for parenteral support has decreased from
baseline while on therapy with the requested medication.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
97
GAVRETO
Products Affected
Gavreto
PA Criteria
Criteria Details
Indications
All FDA-approved Indications, Some Medically accepted Indications.
Off-Label Uses
Recurrent or advanced rearranged during transfection (RET)
rearrangement-positive non-small cell lung cancer
Exclusion
Criteria
N/A
Required
Medical
Information
For non-small cell lung cancer, patient must meet all of the following: 1)
The disease is recurrent, advanced, or metastatic, and 2) The tumor is
rearranged during transfection (RET) fusion-positive or RET
rearrangement-positive.
Age Restrictions
Non-small cell lung cancer: 18 years of age or older. Medullary thyroid
cancer and thyroid cancer: 12 years of age or older.
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
98
GILENYA
Products Affected
Gilenya CAPS 0.5MG
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
N/A
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
99
GILOTRIF
Products Affected
Gilotrif
PA Criteria
Criteria Details
Indications
All FDA-approved Indications.
Off-Label Uses
N/A
Exclusion
Criteria
N/A
Required
Medical
Information
For non-small cell lung cancer (NSCLC): Patient meets either of the
following:
1) Patient has metastatic squamous NSCLC that progressed after
platinum-based chemotherapy, OR 2) Patient has sensitizing EGFR
mutation-positive disease.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Plan Year
Other Criteria
N/A
100